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Guided Imagery: Reducing Stress and Improving Well-being in Pregnant Adolescents

Primary Purpose

Stress, Psychological

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Guided Imagery
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stress, Psychological

Eligibility Criteria

13 Years - 21 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • All pregnant students ages 13-21 enrolled in the alternative education program for parenting teens were eligible to participate

Exclusion Criteria:

  • Participants were excluded from the study if they delivered their babies prior to completing four sessions of guided imagery intervention.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Guided Imagery

    Arm Description

    Participants listened to a pregnancy-specific guided imagery recording on four separate occasions during their pregnancies. Perceived stress was measured immediately pre and post each listening session using the Perceived Stress Measure-9 (PSM-9).

    Outcomes

    Primary Outcome Measures

    Change in Psychological Stress Measure-9 (PSM-9) score
    Participants will complete the PSM-9 before and after listening to guided imagery sessions for each of the 4 weekly intervention sessions. The Psychological Stress Measure-9 (PSM-9) is a 9 item questionnaire measuring stress. The original form was published in Canada by Louise Lemyre, PHD and Rejean Tessier, PHD in 1988 and the 9 item was published in 2002. Each response rests on an 8 point likert scale. For general surveys of health and well-being in the workplace, an abridged 9-item version was developed to meet a variety of research needs and applications. The PSM-9 version is used at Hydro-Quebec and Renault (France) as well as in public service, hospitals, community services, and private practice. It has the same psychometric qualities of reliability, validity, and internal consistency (.89) and maintains the same heuristic value for statistics: normality of distribution and responsiveness (Lemyre, Chair, & Lalande-Markon, 2009).

    Secondary Outcome Measures

    Full Information

    First Posted
    December 1, 2015
    Last Updated
    November 2, 2018
    Sponsor
    University of Wisconsin, Madison
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02636374
    Brief Title
    Guided Imagery: Reducing Stress and Improving Well-being in Pregnant Adolescents
    Official Title
    Guided Imagery: Reducing Stress and Improving Well-being in Pregnant Adolescents
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2012 (undefined)
    Primary Completion Date
    November 2018 (Actual)
    Study Completion Date
    November 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Wisconsin, Madison

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to examine the effects of a guided imagery intervention on perceived stress in pregnant adolescents.
    Detailed Description
    Pregnant adolescents attending a local alternative education program will be subjects of this study. Students will participate in four, 15 minute guided imagery sessions over about a 4-6 week period. They will complete a pregnancy specific stress questionnaire before beginning and after completion of the guided imagery protocol. The students will also complete a short 9-question stress measure before and after each of the individual guided imagery sessions. The specific aims are: to evaluate whether a guided imagery intervention reduces perceived stress in pregnant adolescents; and to evaluate whether a guided imagery intervention enhances well-being in pregnant adolescents. The hypotheses are that the intervention will reduce perceived stress and enhance well-being in these subjects. The purpose of this study is to assess whether employing a guided imagery intervention with pregnant teens and education will reduce perceived stress levels and improve well-being.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stress, Psychological

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    35 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Guided Imagery
    Arm Type
    Experimental
    Arm Description
    Participants listened to a pregnancy-specific guided imagery recording on four separate occasions during their pregnancies. Perceived stress was measured immediately pre and post each listening session using the Perceived Stress Measure-9 (PSM-9).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Guided Imagery
    Intervention Description
    A fifteen minute recording of gentle music together with soft talking to guide relaxation.
    Primary Outcome Measure Information:
    Title
    Change in Psychological Stress Measure-9 (PSM-9) score
    Description
    Participants will complete the PSM-9 before and after listening to guided imagery sessions for each of the 4 weekly intervention sessions. The Psychological Stress Measure-9 (PSM-9) is a 9 item questionnaire measuring stress. The original form was published in Canada by Louise Lemyre, PHD and Rejean Tessier, PHD in 1988 and the 9 item was published in 2002. Each response rests on an 8 point likert scale. For general surveys of health and well-being in the workplace, an abridged 9-item version was developed to meet a variety of research needs and applications. The PSM-9 version is used at Hydro-Quebec and Renault (France) as well as in public service, hospitals, community services, and private practice. It has the same psychometric qualities of reliability, validity, and internal consistency (.89) and maintains the same heuristic value for statistics: normality of distribution and responsiveness (Lemyre, Chair, & Lalande-Markon, 2009).
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: All pregnant students ages 13-21 enrolled in the alternative education program for parenting teens were eligible to participate Exclusion Criteria: Participants were excluded from the study if they delivered their babies prior to completing four sessions of guided imagery intervention.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Karla Ausderau, PhD, OTR/L
    Organizational Affiliation
    University of Wisconsin, Madison
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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